title: External pancreatic duct stent decreases pancreatic fistula rate after pancreaticoduodenectomy: prospective multicenter randomized trial.
abstract: OBJECTIVE
  Pancreatic fistula (PF) is a leading cause of morbidity and mortality after pancreaticoduodenectomy (PD). The aim of this multicenter prospective randomized trial was to compare the results of PD with an external drainage stent versus no stent.
  
  
  METHODS
  Between 2006 and 2009, 158 patients who underwent PD were randomized intraoperatively to either receive an external stent inserted across the anastomosis to drain the pancreatic duct (n = 77) or no stent (n = 81). The criteria of inclusion were soft pancreas and a diameter of wirsung <3 mm. The primary study end point was PF rate defined as amylase-rich fluid (amylase concentration >3 times the upper limit of normal serum amylase level) collected from the peripancreatic drains after postoperative day 3. CT scan was routinely done on day 7.
  
  
  RESULTS
  The 2 groups were comparable concerning demographic data, underlying pathologies, presenting symptoms, presence of comorbid illness, and proportion of patients with preoperative biliary drainage. Mortality, morbidity, and PF rates were 3.8%, 51.8%, and 34.2%, respectively. Stented group had a significantly lower overall PF (26% vs. 42%; P = 0.034), morbidity (41.5% vs. 61.7%; P = 0.01), and delayed gastric emptying (7.8% vs. 27.2%; P = 0.001) rates compared with nonstented group. Radiologic or surgical intervention for PF was required in 9 patients in the stented group and 12 patients in the nonstented group. There were no significant differences in mortality rate (3.7% vs. 3.9%; P = 0.37) and in hospital stay (22 days vs. 26 days; P = 0.11).
  
  
  CONCLUSIONS
  External drainage of pancreatic duct with a stent reduced. PF and overall morbidity rates after PD in high risk patients (soft pancreatic texture and a nondilated pancreatic duct).
authors.affiliation: Pôle des Pathologies Digestives, Hépatiques et de la Transplantation, Hôpital de Hautepierre, Université de Strasbourg, France. patrick.pessaux@chru-strasbourg.fr
authors.forename: Patrick
authors.initials: P
authors.lastname: Pessaux
authors.forename: Alain
authors.initials: A
authors.lastname: Sauvanet
authors.forename: Christophe
authors.initials: C
authors.lastname: Mariette
authors.forename: François
authors.initials: F
authors.lastname: Paye
authors.forename: Fabrice
authors.initials: F
authors.lastname: Muscari
authors.forename: Antonio Sa
authors.initials: AS
authors.lastname: Cunha
authors.forename: Bernard
authors.initials: B
authors.lastname: Sastre
authors.forename: Jean-Pierre
authors.initials: JP
authors.lastname: Arnaud
mesh_terms: D000368:Aged; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007430:Intraoperative Care / Q000379:methods*; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D010183:Pancreatic Ducts / Q000601:surgery*; D010185:Pancreatic Fistula / Q000209:etiology / Q000517:prevention & control*; D010190:Pancreatic Neoplasms / Q000401:mortality / Q000601:surgery; D016577:Pancreaticoduodenectomy / Q000009:adverse effects / Q000379:methods*; D011183:Postoperative Complications / Q000517:prevention & control; D011446:Prospective Studies; D012016:Reference Values; D018570:Risk Assessment; D018709:Statistics, Nonparametric; D015607:Stents; D015996:Survival Rate; D016896:Treatment Outcome